Duns Number:194775557
Device Description: Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler (MDI) aero Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler (MDI) aerosol medication delivery. It is comprised of a MDI adapter port, Holding chamber, a one way valve, Mouth Piece and mouthpiece cap
Catalog Number
-
Brand Name
EasiVENT Valved Holding Chamber
Version/Model Number
49502-207
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
8ff4e971-7aa1-4a5c-9f86-d0bc7a61c5fd
Public Version Date
January 21, 2022
Public Version Number
3
DI Record Publish Date
April 10, 2018
Package DI Number
30349502207014
Quantity per Package
12
Contains DI Package
00349502207013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |